(l) FDCA means the United States Federal Food, Drug, and Cosmetic
Act.
(m) Fraud means common law fraud with respect to the making of the representations or warranties in
Article IV or Article V hereof, as applicable.
(n) Governmental Entity means any supranational,
national, state, municipal, local or foreign government, any court, tribunal, arbitrator, administrative agency, commission or other governmental official, authority or instrumentality, in each case whether domestic or foreign, any stock exchange or
similar self-regulatory organization or any quasi-governmental, private body or arbitral body exercising any executive, legislative, judicial, quasi-judicial, regulatory, taxing, importing, administrative or other governmental or quasi-governmental
authority.
(o) Judgment means any orders, writs, injunctions, awards, judgments, settlements, stipulations,
determinations, and decrees entered by or with any Governmental Entity.
(p) Knowledge means, with respect to
Seller, the actual knowledge of Leslie Wilder (Head of Regulatory Science), Christopher Krawtschuk (Chief Financial Officer), Andrew Obenshain (Chief Executive Officer), Joe Vittiglio (Chief Business and Legal Officer) and Rich Colvin (Chief Medical
Officer), after reasonable inquiry.
(q) Legal Requirements means any federal, state, foreign, local, municipal
or other law, statute, constitution, principle of common law, resolution, ordinance, code, edict, decree, rule, regulation, ruling or requirement issued, enacted, adopted, promulgated, implemented or otherwise put into effect by or under the
authority of any Governmental Entity and any Orders or Judgment applicable to a Party or to any of its assets, properties or businesses. Legal Requirements shall include, as applicable, any obligations, responsibilities, requirements, parameters and
conditions relating to the Priority Review Voucher set forth in (i) the Approval Letter, (ii) any other correspondence received by Seller or its Affiliates from the FDA regarding the Priority Review Voucher, (iii) Section 529 of
the FDCA (21 U.S.C. § 360ff), or (iv) in the FDAs Draft Guidance, Rare Pediatric Disease Priority Review Vouchers Guidance for Industry (July 2019).
(r) Liabilities means all debts, liabilities and obligations, whether presently in existence or arising hereafter,
accrued or fixed, absolute or contingent, matured or unmatured, determined or determinable, asserted or unasserted, known or unknown, including those arising under any Legal Requirement, Action or any Contract.
(s) Market or Marketing means to market a drug within the meaning of
Section 529(e)(1) of the FDCA.
(t) Notice of Intent to Use means notification to the FDA not later than
ninety (90) days prior to the submission of a human drug application of the intent to use the Priority Review Voucher to obtain Priority Review of a human drug application, as described in 21 U.S.C. § 360ff(b)(4)(B)(i).
(u) Order means any order, decree, edict, injunction, writ, award or judgment of any Governmental Entity.
(v) Person means any natural person, company, corporation, limited liability company, general partnership, limited
partnership, trust, proprietorship, joint venture, business organization or Governmental Entity.
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